As you can see, Science-Based Medicine is now back online and fully functional. We have moved to a new host and a faster dedicated server. It seems that our problem was just that we outgrew our previous host.

Sorry for the inconvenience and thank you for your patience. We will now resume our usual schedule of postings.

As many of you have probably noticed, the science-based medicine site has been having connection problems for the last week, and was in fact down for most of Friday. We are actively working on the problem and hopefully will have it fixed soon. The site is functioning now, but remains very slow.

Last week I discussed the dismal results of the “Gonzalez Trial” for cancer of the pancreas,* as reported in an article recently posted on the website of the Journal of Clinical Oncology. I promised that this week I’d discuss “troubling information, both stated and unstated [in the report],” and also some ethical issues. More has come to light in the past few days, including Nicholas Gonzalez’s own voluminous, angry response to the JCO article. I’ll comment upon that below, but first a brief review.

The trial was begun in 1999 under the auspices of Columbia University, after Rep. Dan Burton had pressured NCI Director Richard Klausner to fund it. It was originally conceived as a randomized, controlled trial comparing the “Gonzalez Regimen” to standard chemotherapy for cancer of the pancreas. In the first year, however, only 2 subjects had been accrued, purportedly because those seeking Gonzalez’s treatment were not willing to risk random assignment to the chemotherapy arm. In 2000, the protocol was changed to a “prospective, cohort study” to allow potential subjects to choose which treatment they would follow. Gonzalez himself was to provide the ‘enzyme’ treatments.

After that there was little public information about the trial for several years, other than a few determination letters from the Office of Human Research Protections and a frightening account of the experience of one subject treated by Gonzalez. By 2006 or so, those of us who pay attention to creeping pseudomedicine in the academy were wondering what had become of it. About a year ago we found out: the trial had been quietly “terminated” in 2005 after it met “pre-determined stopping criteria.” As explained here, that meant that the Gonzalez group had not fared well.

Four years after the trial’s ‘termination,’ the report was finally published: The Gonzalez cohort had not only fared much worse than the cohort that received chemotherapy, but it had fared worse than a comparable group of historical controls. Here, again, is the survival graph from the JCO paper:

The Gonzalez group had also fared much worse in ‘quality of life’ scores, which included a measure of pain.

Now let’s read between the lines. Forgive me for taking shortcuts; I’m a little pressed for time. (more…)

Kevin Trudeau has made millions of dollars selling dubious medical products. He started his snake-oil salesman career selling coral calcium through infomercials. Trudeau claimed that this magical form of calcium could cure cancer and whatever ails you. The Federal Trade Commission (FTC) investigated Trudeau, who was making millions off his claims, and found that he was being, let us say, less than honest. As a result the FTC banned Trudeau from selling health products through infomercials.

But Trudeau is tenacious and creative – an innovator. Prior to getting into infomercials he was small time – he was convicted for writing bad checks and credit card fraud and spent some time in prison. I always find it interesting that convicted con-artists seem to hit upon such well-guarded secrets. Dennis Lee claims to have found the secret of limitless energy, if only he were not attacked by Big Oil and a corrupt government. Kevin Trudeau claims to have found the cures for just about everything, but The Man is trying to shut him down.

Undeterred by the FTC ban, Trudeau decided that even though he could not sell health products he could sell information – that was protected under free speech – so he started selling books through infomercial, including Natural Cures They Don’t Want You To Know About. Trudeau claimed he went from writing bad checks to discovering not only hundreds of natural cures but uncovering a government and Big Medicine conspiracy to keep this vital information from the public.

The PowerPoint presentation that I gave at the Skeptic’s Toolbox workshop at the University of Oregon on August 7, 2009 is up on their website with the complete text of what I said. The theme of the workshop was scientific method. The title of my talk is “Tooth Fairy Science and Other Pitfalls: Applying Rigorous Science to Messy Medicine.” Click here for the link. It covers a lot of things that are pertinent to the subjects we discuss on this blog, and I thought some of our readers might enjoy it. I put in a lot of information and some good cartoons. Note: this was a talk to the general public, not an academic presentation, and it does not include citations or references.

Review

One of the more bizarre and unpleasant “CAM” claims, but one taken very seriously at the NIH, at Columbia University, and on Capitol Hill, is the cancer “detoxification” regimen advocated by Dr. Nicholas Gonzalez:

Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

Veteran SBM readers will recall that in the spring of 2008 I posted a series of essays* about this regimen and about the trial that compared it to standard treatment for subjects with cancer of the pancreas. The NIH had funded the trial, to be conducted under the auspices of Columbia, after arm-twisting by Rep. Dan Burton [R-IN], a powerful champion of quackery, and much to the delight of the “Harkinites.”

In the fall of 2008 I posted an addendum based on a little-known determination letter that the Office for Human Research Protections (OHRP) had sent to Columbia during the previous June. The letter revealed that the trial had been terminated in October, 2005, due to “pre-determined stopping criteria.” This demonstrated that Gonzalez’s regimen must have been found to be substantially worse than the current standard of care for cancer of the pancreas, as ineffective as that standard may be. I urge readers who require a review or an introduction to the topic to read that posting, which also considered why no formal report of the trial had yet been made available.

Now, finally, the formal report has been published online by the Journal of Clinical Oncology (JCO):

The marketing of so-called CAM or integrative medicine continues. These terms are just that – marketing. They are otherwise vacuous, even deceptive, and meant only to conceal the naked fact that most medical interventions that hide under the CAM/integrative umbrella lack plausibility or credible evidence that they actually work.

The essence of the editorial can be boiled down to this – proponents of integrative medicine are disappointed that scientific research has not validated their failed modalities. Therefore they want to weaken the rules of evidence so that they can get the results they desire.

I can understand how wading into the cesspool that is conflict of interest can leave one cynical. But cynicism and suspicion turned up to “11” is no longer bravery—it’s crankery. It’s not his snarkiness that burns—it’s his inability to separate his biases from the facts.

It’s not like the pharmaceutical industry doesn’t deserve to be taken to the wood shed. Examples of unethical and downright immoral practices abound, such as ghost-writing, fake journals, and a host of other sins. But the industry has also helped develop a most remarkable pharmacopeia which saves and improves countless lives. There is good, and there is bad. And telling the two apart, well, that makes all the difference.

He tends to go for headlines that hit hard, but miss the point entirely. Examples:

Angioplasty Found to be Useless Waste of Money: he cites a journal article which he says concluded that “not useful for patients with stable coronary artery disease (CAD). ” His title would be accurate if angioplasty were used only in stable CAD—it is not.

Should I Take Aspirin or Put a Gun To My Head?: here, he sort of gets the difference between primary and secondary prevention, but not really. He also likes to admit that the data contradict his conclusion but he’s nice enough to say, “screw the data”:

Although technically the risk of stomach bleeding is outweighed by the heart benefits of aspirin (which can only be shown when large numbers of patients are studied), in terms of what that means to you the differences are clinically meaningless.

This Just In: Breast Cancer Screening Essentially Useless: yes, Doug, breast cancer screening doesn’t benefit everyone equally. For example, the prevalence of breast cancers in men is low enough that recommending it for you would be stupid—like your article.

If I read one more crappy article about placebos, something’s gotta give, and it’s gonna be my head or my desk. Wired magazine has a new article entitled, “Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why.” Frequent readers of skeptical and medical blogs will spot the first problem: the insanely nonsensical claim that “placebos are getting better”. This not only “begs the question,” but actually betrays a fundamental misapprehension of the concept. I’ve written several times about the nature and ethical implications of placebos, but it’s time for a serious smackdown. (more…)

The President’s Council of Advisors on Science and Technology recently submitted its report to the president in which they stated that this influenza season might kill 30-90,000 people in the US. This forecast of the upcoming season caught the media’s attention and appears to have stoked the public interest in influenza. We have had many requests for more information about influenza here at SBM, and so in this post I am going to discuss the basics of influenza and try to put the current pandemic and upcoming season in perspective.

I find it is best to start at the beginning.

What Is Influenza?

Within the public sphere, “The flu” has become shorthand for “I feel like crap.” I suspect that this is part of the reason why some people think the influenza vaccine doesn’t work. Medically speaking, however, influenza is a very specific family of viruses that cause a reasonably narrow set of problems for humans.

The influenza season in the Northern hemisphere usually runs from October through May, with a peak mid-February. Every season in the US between 5-20% of the US population is infected by influenza, and while the majority of people recover well from an influenza infection, not everyone will. Annually 200,000 people are hospitalized, and on average 36,000 will die either from influenza or its complications.

The classic influenza infection incubates for 1-4 days after exposure. Its onset is rapid, with most people experiencing high fever, headache, muscle aches, dry cough, sore throat, and nasal congestion. Gastro-intestinal symptoms like nausea, vomiting, and diarrhea are less common. Symptoms last from several days to almost two weeks, and a person is contagious from one day before symptoms begin to more than a week after symptom onset.

There are many strains of influenza. The current seasonal influenza is made up of three different influenza subtypes: A(H3N2), A(H1N1), and B. Don’t confuse the seasonal A(H1N1) strain with the current pandemic 2009 A(H1N1); they are distinct. I will refer to them as A(H1N1) for the seasonal strain, and 2009 (H1N1) for the pandemic “swine flu” strain. Influenza B is less common, less virulent, has a slower mutation rate, and is thus a lesser risk; the rest of this discussion is focused on Influenza A. (more…)